Aortic Stenosis
Conditions
Brief summary
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Detailed description
This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.
Interventions
DEVICEVitaFlow™ II Transcatheter Aortic Valve System
VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire
Sponsors
Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age≥70 years; 2. Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area\<0.8cm² (or EOA index\<0.5cm²/m²); 3. NYHA≥II class; 4. Estimated life-expectancy\>12 months after implantation of the prosthetic valve; 5. Anatomically suitable for the transcatheter aortic valve implantation procedure; 6. The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
Exclusion criteria
1. Acute myocardial infarction (MI) in last 30 days before the treatment; 2. Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve； 3. Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation; 4. Previous implantation of heart valve at any position； 5. Hemodynamic instability requiring mechanical hemodynamic support devices; 6. Need for emergency surgery for any reason; 7. Hypertrophic cardiomyopathy with obstruction; 8. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%;Severe right ventricular dysfunction; 9. Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months; 10. Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements. 11. Congenital aortic valve stenosis or unicuspid aortic valve; 12. Vascular diseases or anatomical condition preventing the device access; 13. Active endocarditis or other active infections at the time of treatment; 14. Participating in another trial and the primary endpoint is not achieved. 15. Inability to comply with the clinical investigation follow-up or other requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all-cause mortality at 12 months post implantation | 12 months post implantation | Rate of all-cause mortality including cardiovascular and non-cardiovascular death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valve function-mean prosthetic valve gradient | at 30 days, 6 months, and 1 year post implantation | Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg) |
| Valve function- effective orifice area | at 30 days, 6 months, and 1 year post implantation | Effective orifice area measured by transthoracic echocardiography (TTE)(in cm\^2) |
| Valve function- degree of prosthetic valve regurgitation | at 30 days, 6 months, and 1 year post implantation | Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE) |
| Rate of safety events according to VARC2 | at 30 days, 6 months, 1 year and annually up to 5 years post implantation | Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, conduction disturbance and arrhythmias, and new permanent pacemaker implantation |
| Rate of procedure success | at immediate post implantation | Rate of procedure success, assessed by the device success and the peri-procedural complications |
| Rate of major adverse cardiac and cerebrovascular events(MACCE) | at 30 days, 6 months, 1 year and annually up to 5 years post implantation | Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances |
| Rate of device success | at immediate post implantation | Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function |
| Rate of balloon pre-dilation success | at immediate post implantation | Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter |
| Rate of balloon post-dilation success | at immediate post implantation | Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter |
| Rate of other TAVI-related complications | at 30 days, 6 months, 1 year and annually up to 5 years post implantation | Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, and TAV-in-TAV |
Countries
China
Contacts
Primary ContactBi Jie
Backup ContactZhujun Cai, PhD
Outcome results
None listed